Study of Escitalopram (Lexapro) for Improvement of Depressive Symptoms and Quality of Life in People With Multiple Sclerosis (MS) or Amyotrophic Lateral Sclerosis (ALS) Who Are Experiencing Depression - Full Text View

Sponsor:	University of South Carolina
Information provided by:	University of South Carolina
ClinicalTrials.gov Identifier:	NCT00965497

Purpose

The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.

Condition	Intervention	Phase
Major Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis	Drug: escitalopram (Lexapro)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Depression Multiple Sclerosis

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University of South Carolina:

Primary Outcome Measures:

Improvement in depressive symptoms as assessed by change from baseline to eight weeks scores on Hamilton Depression Scale (HAM-D 17). [ Time Frame: 2-8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in scores on CGI-I , CGI-S, BDI-II, BAI, McGill Quality of Life Scale, , Edmonton Symptom Assessment System, ALS Functional Rating Scale (ALS only) Expanded Disability Status Scale (MS only) from baseline to end of treatment. [ Time Frame: 2-8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	July 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open-label, single arm: Experimental All patients will receive the intervention	Drug: escitalopram (Lexapro) After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.

Arms

Assigned Interventions

Open-label, single arm: Experimental

All patients will receive the intervention

Drug: escitalopram (Lexapro)

After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.

Detailed Description:

This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients between 18 and 70 years of age with documented ALS or MS,
DSM-IV episode of non-psychotic Major Depression,
≥14 score on the 17-item HAM-D,
Ability to give informed consent.

Exclusion Criteria:

History of psychotic disorders,
Psychotic depression,
Bipolar depression,
Suicide risk,
History of substance abuse in the previous 6 months,
History of unstable medical disorders,
Pregnancy or planning for pregnancy,
Severity of ALS or MS that limits participating in the study protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965497

Locations

United States, South Carolina
University of South Carolina School of Medicine
Columbia,, South Carolina, United States, 20203

Sponsors and Collaborators

University of South Carolina

Investigators

Principal Investigator:

Meera Narasimhan, MD

University of South Carolina School of Medicine

More Information

Additional Information:

Click here for more information about this study....Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) and Depression This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Cohen SR, Mount BM, Strobel MG, Bui F. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med. 1995 Jul;9(3):207-19.

Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40.

Responsible Party:	University of South Carolina School of Medicine ( Meera Narasimhan, MD )
Study ID Numbers:	LXP-113
Study First Received:	August 7, 2009
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00965497 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of South Carolina:

Amyotrophic Lateral Sclerosis
ALS
Multiple Sclerosis
MS
Major Depression

Depression
Major Depressive Disorder
antidepressants
Escitalopram
Lexapro

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Spinal Cord Diseases
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Neurodegenerative Diseases
Multiple Sclerosis
Pathologic Processes

Neuromuscular Diseases
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Dexetimide
Motor Neuron Disease
Antidepressive Agents
Autoimmune Diseases of the Nervous System
Depression
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Central Nervous System Diseases
Sclerosis

ClinicalTrials.gov processed this record on February 08, 2010